Study of Energy Requirements in Critically Ill Newborns

This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Indianapolis,
Indiana46202

Purpose:

OBJECTIVES:
I. Determine the total energy expenditure in term and preterm infants in both well and ill
states using the doubly labeled water method.

Study summary:

PROTOCOL OUTLINE: Patients are assigned to one of three groups according to gestational age
(24-28 weeks estimated gestational age (EGA) vs 29-34 weeks EGA vs 35 weeks EGA and over)
and severity of respiratory illness (need for high frequency ventilation vs stable
conventional ventilator settings or extubated within past 24 hours vs no need for mechanical
ventilation).
Patients receive water labeled with deuterium and oxygen O 18 by mouth or by gastrostomy
tube on days 1 and 7. Urine samples are collected prior to the first dose, 4-6 hours after
the first dose, and then every 24 hours until the second dose. All urine is collected for
4-6 hours after the second dose. Samples are analyzed by dual inlet isotope ratio mass
spectrometry.

Criteria:

PROTOCOL ENTRY CRITERIA:
--Disease Characteristics--
Infants with estimated gestational age (EGA) of at least 24 weeks with respiratory illness
who are on high frequency ventilation (HFOV) and meet the following conditions:
Appropriate size for gestational age (AGA) No congenital anomalies No medical
complications, including seizures and necrotizing enterocolitis
OR
Control infants with EGA of at least 24 weeks Must meet 1 of the following conditions:
Requirement for stable conventional ventilator settings with respiratory index score of
less than 2.5 and/or extubated within past 24 hours No requirement for mechanical
ventilation Must meet all of the following conditions: AGA No congenital anomalies No
medical complications, including seizures and necrotizing enterocolitis No documented
sepsis by positive blood culture No supplemental oxygen use (infants 35 weeks EGA and over
only)
--Prior/Concurrent Therapy--
HFOV group: Concurrent surfactant, theophylline, or inotrope (vasopressor) therapy allowed
Control group: No concurrent inotrope (vasopressor) therapy

NCT ID:

NCT00006274

Primary Contact:

Study ChairCatherine A. LeitchIndiana University

Backup Contact:

N/A

Location Contact:

Indianapolis, Indiana 46202United States

Catherine A. LeitchPhone: 317-274-4920

Site Status: Recruiting

Data Source: ClinicalTrials.gov

Date Processed: September 26, 2017

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.